Tritace

Chemical Name: RAMIPRIL

General Information

This medicine contains the active ingredient ramipril, which is a type of medicine called an ACE inhibitor.

ACE inhibitors work by blocking the action of a compound in the body called angiotensin converting enzyme (ACE). Normally ACE produces another compound called angiotensin II, as part of the body's natural control of blood pressure. Angiotensin II has two actions. Firstly, it causes blood vessels to constrict and narrow, and secondly, it reduces the production of urine by the kidneys. Both these actions increase the pressure within the blood vessels.

As ramipril blocks the action of ACE, it reduces the production of angiotensin II. This means that the blood vessels are allowed to relax to widen and more urine is produced by the kidneys. The overall effect of this is a drop in blood pressure. Ramipril can therefore be used to treat high blood pressure.

The reduced pressure within the blood vessels means that the heart doesn't have to work as hard to pump the blood around the body. Ramipril can therefore be used to improve the symptoms of heart failure, where the heart is not pumping as efficiently. It has also been shown to improve survival in people who are diagnosed with heart failure after suffering a heart attack. Ramipril is usually used in combination with a diuretic medicine to treat heart failure.

Ramipril has been shown to reduce the risk of heart attack, stroke and the need for surgical procedures to improve blood supply to the heart (revascularistion) in various groups of people who are at risk of these problems. These have been established as people aged 55 years or over who have any of the following conditions:

• evidence of heart disease, for example, a previous heart attack, angina not well controlled by medical treatment (unstable angina), or a previous surgical procedure to improve blood supply to the heart, ie multiple heart bypass (coronary artery bypass graft, CABG), or balloon dilation of multiple blood vessels (percutaneous transluminal coronary angioplasty, PTCA)
• previous stroke
• disease of the blood vessels in the extremities (peripheral vascular disease)
• diabetes plus one or more of the following: high blood pressure, high total cholesterol levels, low HDL cholesterol levels, currently a smoker, evidence of previous blood vessel disease or protein in the urine.

Usage of the Drug

• Heart failure, in combination with other medicines
• Mild to moderate high blood pressure
• People with heart failure after suffering a heart attack
• Reducing risk of heart attack, stroke, death and the need for surgery to improve blood supply to the heart (revascularisation) in certain people at risk (listed above)

Warning!

Some people may experience dizziness caused by low blood pressure in the first few days of taking this medicine. This can be relieved by lying down until the symptoms pass. If affected you should avoid performing potentially hazardous tasks such as driving or operating machinary.

There is insufficient information regarding the safety and efficacy of this medicine in children. It is not recommended for children.

Alcohol may enhance the blood pressure lowering effect of this medicine, which may result in dizziness or fainting.

Your kidney function should be monitored prior to starting and regularly throughout treatment with this medicine.

Stop taking this medicine and consult your doctor immediately if you experience difficulty breathing or swallowing, or swelling of your face, lips, tongue, throat, hands, feet or ankles while taking this medicine.

Use with caution in

• Decreased fluid volume in the body, eg due to diuretic therapy, low salt diet, kidney dialysis, diarrhoea, vomiting, dehydration
• Decreased kidney function
• Decreased liver function
• Diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus, rheumatoid arthritis (collagen vascular diseases)
• Elderly people
• People also taking diuretics

Not to be used in

• Any condition in which there is obstruction to the pumping of blood out of the heart (outflow tract obstruction)
• Breastfeeding
• History of swelling of the lips, face or tongue (angioedema)
• Kidney failure requiring a certain type of haemodialysis (high-flux membrane)
• Low blood pressure (hypotension)
• Narrowing of one of the valves in the heart (mitral valve stenosis)
• Narrowing of the artery which supplies blood to the kidneys (renal artery stenosis)
• Narrowing of the main artery of the body (aortic stenosis)
• People receiving therapy to remove certain types of fat from the blood using a machine (LDL apheresis)
• People with unstable blood circulation

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Seek medical advice from your doctor.

There is no information available about the safety of this medicine during breastfeeding. For this reason, the manufacturer states that it should not be used during breastfeeding. Seek medical advice from your doctor.

Possible Side effects

• Headache
• Dizziness or loss of balance
• Dry mouth
• Impotence
• Chest pain (angina)
• Confusion
• Anxiety and restlessness
• Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
• Dry cough
• Abnormal heart beats (arrhythmias)
• Severe skin rash (erythema multiforme)
• Disturbance in the components of the blood
• Severe swelling of lips, face or tongue (angioedema)
• Flushing
• Alteration in taste
• A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension)
• Decreased sex drive
• Decreased kidney function
• Skin reactions such as rash and itch
• Liver disorders

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

Interaction with other medicines

Ramipril may enhance the blood pressure lowering effect of other medicines that decrease blood pressure, particularly alpha-blocker or diuretic medicines. This may make you feel dizzy, particularly with the first dose of this medicine. If you do feel dizzy or faint after starting this medicine sit or lie down until the symptoms pass, and let your doctor know so that the doses of your blood pressure medicines can be altered if necessary.

If you are already taking a high dose of a diuretic medicine such as frusemide, your doctor may ask you to stop taking it, or reduce your dose, two to three days before you start treatment with this medicine. This is to reduce the risk of causing a severe drop in blood pressure with the first dose of this medicine.

Non-steroidal anti-inflammatory drugs (NSAIDs, eg indometacin) may reduce the blood pressure lowering effect of ramipril, and may increase the risk of a decline in kidney function.

Ramipril may increase the blood levels of lithium, and people taking lithium at the same time as ramipril should have their lithium levels closely monitored.

There may be a risk of raised blood potassium levels (hyperkalaemia) if ramipril is taken with any of the following and these should therefore be avoided:

• potassium-sparing diuretics (eg spironolactone, triamterene, amiloride)
• potassium supplements
• potassium-containing salt substitutes
• ciclosporin.

If you are taking any of these with ramipril your blood potassium level should be monitored.

Ramipril may enhance the blood sugar lowering effect of insulin and oral antidiabetic medicines, with a risk of hypoglycaemia. People with diabetes should therefore carefully monitor their blood sugar while taking this medicine, particularly in the first few weeks of treatment.

There may be an increased risk of side effects on the kidneys if ramipril is taken with any of the following medicines:

• diuretics
• ciclosporin
• non-steroidal anti-inflammatory drugs (NSAIDs).

There may be an increased risk of a drop in the number of white blood cells in the blood if ramipril is taken with any of the following medicines:

• allopurinol
• anti-cancer medicines
• medicines that suppress the immune system
• corticosteroids.

If you are taking ramipiril with any of these medicines you should have regular blood tests to monitor the levels of your blood cells, particularly if you also have decreased kidney function or a collagen vascular disease.